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Friday, October 24, 2014

Sprinting into the race to commercialize an Ebola diagnostic, San Diego's Genalyte says it has developed a 10-minute Ebola test.

The company said its test uses one drop of blood from a finger prick, and offers results in as fast as 10 minutes on its diagnostic platform. The test detects Ebola proteins, even at an early stage of infection before the person is showing obvious symptoms.

Genalyte says validation of the test "is only weeks away," and it wants to work with the federal government to make the test available as rapidly as possible.

The test is based on a proprietary silicon chip technology and run on Genalyte's Maverick Detection System testing platform. The platform is being used now to test for immune system rejection of biologic drugs, such as monoclonal antibodies. It's sold to pharmaceutical companies to help in drug development. The system is also used to test for autoimmune reactions.

For the Ebola test, the chip is coated with antibodies that bind to the viral proteins. Blood flows directly over the chip, Gunn said.

The system can be placed at hospitals and airports, as well as in West Africa where the Ebola outbreak is rapidly spreading, said Cary Gunn, Genalyte's CEO.

The Maverick system can process up to 100 tests per hour per instrument. Each instrument costs around $120,000, and the chips will cost about $10 each, Gunn said. The system requires standard electrical power. But the power doesn't have to be on the grid, it can come from a generator, he said.

Ebola researcher Erica Ollmann Saphire said by email that the biggest need in Africa is for rapid tests "that would function well in resource-poor environments."

"There is no electricity in many regions affected by this outbreak, for example,"said Ollmann Saphire, of The Scripps Research Institute. "It would also be good to know specificity and sensitivity - how many false negatives and positive there are and how little viral material can still be detected. These are useful numbers to know for any diagnostic. If testing is still in progress, they may not have those figures."

Gunn said Genalyte will work with government officials and health organizations to provide the needed information. The device comes with a "pretty robust" power converter, he said, allowing it to tap into a variety of sources.

The tests can be run in a standard or high-sensitivity mode, Gunn said. Standard sensitivity tests take 10 minutes, while high-sensitivity tests take 15 minutes.

Gunn said the machine is fairly easy to operate.

"All you need to do is take a fingerprick of blood, put it in a vial or a 96-well tray, put it into the instrument and press go," Gunn said. "Our workflow is simple enough that an untrained technician can do this."

Genalyte is submitting evidence of this ease of use to federal regulators to help get a rapid emergency use authorization for the test.

To validate the test, the company is working with government labs that have access to viral samples, Gunn said. Once that is done, Genalyte can file for an emergency use authorization with the Food and Drug Administration.